Interpretation of guidance on non-clinical safety evaluation for nanomedicines / 药学学报

With the rapid development of nanotechnology, the research and development of nanomedicines have become one of the development directions of drug innovation. Nanomedicines have special physical and chemical properties, such as nanoscale effects and nanostructure effects, so they have special biological properties, which may change the pharmacokinetic profiles such as absorption and tissue distribution of drug molecules, and thus affect their safety and effectiveness. There are many special concerns on the non-clinical safety evaluation of nanomedicines at the basis of ordinary drug because of the particularity of nanomedicines. On August 25, 2021, China issued Guidance on Non-clinical Safety Evaluation for Nanomedicines(interim). This article interprets comprehensively the guidance, focuses on the key points of non-clinical safety evaluation for nanomedicines, and expounds combined with some cases, aiming to provide reference for drug researchers.

Relationship between pre-clinical toxicity and efficacy of traditional Chinese medicine / 中国中药杂志

Based on the different category of syndromes between traditional Chinese medicine(TCM) and Western medicine, the relationship between the efficacy and non-clinical toxicity of the TCM was analyzed. If TCM preparations have the same pharmacological targets to treat disease with modern medicine or the Chinese herbal preparations treat the diseases with its toxicity, their toxicity often exhibits the amplification and extension of activity; on the other hand, if TCM preparations have overlapped pharmacological targets but not completely the same with modern medicine, or if they have totally different pharmacological targets, the toxicity of TCM could not be inferred by pharmacological activity. With the great progress in extraction and separation technique for active parts of TCM as well as the application of some novel technique and excipients, some toxicity may be from the reactions unrelated with the pharmacological activity. In conclusion, better design and quality control could be obtained by understanding the relationship between pharmacological and toxicological study for the investigation of new traditional medicine.

Concern points and considerations for pharmacodynamic study design of new traditional Chinese medicines / 中国中药杂志

Pharmacodynamic (PD) studies play an important role in research and development of new traditonal Chinese medicines (TCMs). Phamacologic and toxicologic studies that aim to research drug ability can provide supporting data for the clinical trials and reduce the risk of clinical trials. In recent years, PD studies in TCMs are developing and progressing, but there are still some problems affecting the value of PD studies in the development of new TCMs. The value of PD studies depends on scientific and rational study design. This article summaries some defects in PD study design of new TCMs that are common in the application data, including defects in study type, testing targets, dosing, duration of administration, control group, testing time. This article also discusses some points of concern and specific requirements for PD study design of new TCMs.

Consideration about data management and biostatistics analysis from a FDA's botanical drug approval case / 中国中西医结合杂志

FDA approved the first botanical drug of non-simplex ingredient on 31st Oct 2006. The new drug's trade name is Veregen 15% Ointment. Veregen succeeded in coming into the market in U.S, which attracts other countries and regions' attention where traditional herbs have been always used. From the viewpoints of data management and biostatistics method, the authors will think and discuss this case well, and hope to promote domestic new drug investigation.